Clinical Trial Details
| Trial ID: | L6436 |
| Source ID: | NCT01747083 |
| Associated Drug: | Fdc(Gemigliptin/Metformin Hcl Sustained Release 50/1000mg(25/500mg X 2tablets)) |
| Title: | Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets)) |
| Outcome Measures: | Primary: AUClast, To evaluate AUClast of gemigliptin and metformin, up to 48 h post-dose|Cmax, TO evaluate Cmax of gemigliptin and metformin, up to 48 h post-dose | Secondary: AUCinf, To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin), up to 48 h post-dose|Tmax, To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim), up to 48h post-dose|t1/2, To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim), up to 48 h post-dose|Cmax, To evaluate Cmax of LC15-0636(active metabolite of gemigliptim), up to 48h post-dose|AUClast, To evaluate AUClast of LC15-0636(active metabolite of gemigliptim), up to 48h post-dose |
| Sponsor/Collaborators: | Sponsor: LG Life Sciences |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: |
| Start Date: | 2013-01 |
| Completion Date: | 2013-04 |
| Results First Posted: | |
| Last Update Posted: | 2013-10-24 |
| Locations: | Asan Medical Center, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01747083 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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